Circumcision has been practiced for religious and/or health purposes for centuries. In the United States, it is the most common operation performed on male infants and is performed on older children and adults with some regularity as well. The present invention relates to a surgical dressing which is particularly designed to facilitate and expedite the operation of circumcision in these older children including, e.g., frenulectomies and splitting unretractable dorsal foreskin as a part thereof.
An instrument in common use in the surgical art to facilitate circumcision is known generally as a circumcision clamp. This instrument is designed to position the parts of the penis to facilitate circumcision, the actual circumcision being effected by means of a scalpel or other cutting instrument which is extraneous to the clamp itself and separately manipulated by the surgeon.
In infants, circumcision is most commonly performed using a metal bell-shaped Gomco clamp, similar to that shown in U.S. Pat. No. 2,294,852, which crushes the thin infant foreskin and fuses the outer and inner layers, eliminating the need for suturing. Another device used in infants, disclosed in U.S. Pat. No. 3,056,407 and known as a "Plastibell," depends on a ligature to crush the foreskin.
The thickness and vascularity of the foreskin in the adult and older child, as well as the variability in size and shape of the glans penis, preclude the use of such fixed-sized crushing circumcision clamps. Thus, circumcision in adults and children ordinarily entails minor surgery, usually accomplished on an outpatient basis using local anesthesia in the adult or general anesthesia in the child. The usual operating time is between 15 and 20 minutes. Excision of the foreskin can be relatively bloody, and the placement of multiple absorbable sutures is tedious and routine. These sutures lose their tensile strength unpredictably, resulting often in secondary wound separation or bleeding from one to three weeks after surgery. Infection can be a hazard following circumcision due to difficulty in effectively dressing the penis, particularly in active children or adults. Further, the cost of outpatient circumcision, including surgeon's fee, operating room charges, and anesthesia can approach $1,500, depending on the geographical region.
Moreover, the reasons behind adult circumcision need to be examined carefully. Two of such reasons include non-retractable foreskin and tight frenulum which tends to tear. These reasons must be addressed in the adult circumcision device in general and in the specific treatments of these conditions. Large, bulky clamps do not comport with desires and practicalities of juveniles and adults requiring these procedures. The circumcision clamp in SU 1232-234 is an example of a clamp that, not only does adjust to different sized penises, but contains large bulky projections through which a screw fits. Such bulky projections would be rejected by male juveniles and adults requiring circumcision.
Thus, there exists a need for an adjustable hemostatic dressing device which would enable performance of circumcision on children and adults on an outpatient basis, with local anesthesia only, in a non-operating room (i.e., office) environment, without the need for sutures or additional dressings. Such a device would not only offer time savings and cost reduction, but lowered morbidity as well. It is estimated that such a device could provide cost reductions approaching 90% and time savings in the range of 60%-80%.